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Benfield, A.H

Long-term nutritional follow-up is a cornerstone of safe post-bariatric care, and patients who have undergone gastric sleeve surgery should regard ongoing monitoring not as optional, but as an integral part of their surgical outcome

21 CFR 211.100(a) FDA cited 21 CFR 211.100(a) for failure to establish adequate written procedures for production and process control most frequently: 38 times across the 94 inspection-based warning letters reviewed